Cleared Traditional

Actinia? hip stems

K232371 · Implantcast GmbH · Orthopedic

Oct 2023

Decision

72d

Days

Class 2

Risk

About This 510(k) Submission

K232371 is an FDA 510(k) clearance for the Actinia? hip stems, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Implantcast GmbH (21614 Buxtehude, DE). The FDA issued a Cleared decision on October 19, 2023, 72 days after receiving the submission on August 8, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K232371 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 08, 2023
Decision Date	October 19, 2023
Days to Decision	72 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353